MediHoney®

Basic Information

• Brand Name: MediHoney®
• Primary DI: 10381780486909
• Version / Model: 31012
• Catalog Number: 31012
• Company Name: ACELL, INC.
• Labeler DUNS: 137258252
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-03-06
• Public Version: 8
• Public Version Date: 2023-06-08
• Public Version Status: Update
• Public Device Record Key: debe9271-dd26-4101-ac49-a3f4909831a9

Device Description

MediHoney® Calcium Alginate Dressing with Active Leptospermum Honey

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FRO	Dressing, wound, drug	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
47474	Exudate-absorbent dressing, hydrophilic-gel, antimicrobial	A wound covering, typically made of a hydrocolloid, hydrofibre, chitosan or alginate (salts and acids extracted from seaweed), intended to produce a water-absorbent gel upon contact with wound exudate, and that contains an antimicrobial agent [e.g., silver (Ag), honey]. It assists in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) for minimal wound maceration, allowing wound debridement, and creating a moist wound-healing environment while reducing microbial colonization within the dressing. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, or powder. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30381780486903	GS1	Case	4	In Commercial Distribution
Primary	10381780486909	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			3/4" x 12"
Device Size Text, specify			1.9 cm x 30.5 cm

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Do not use if package is damaged
• Type: Storage Environment Temperature
• Temperature Range: 50 – 77 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 10 – 25 Degrees Celsius